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PRODUCT INFORMATION

DECA-DURABOLIN

(nandrolone decanoate)

NAME OF THE MEDICINE

Deca-Durabolin

50 mg/mL (Solution for injection of nandrolone decanoate)

Molecular Formula: C28H44O3 Molecular mass: 428.7 Cas. No: 360-70-3

Chemical Name: 3-oxo-estr-4-en-17-yl decanoate Deca-Durabolin is an androgenic oily preparation for intramuscular administration.

DESCRIPTION Nandrolone decanoate is a white to creamy white, crystalline powder. It is practically insoluble in water but is freely soluble in chloroform, ethanol, ether, fixed oils and esters. Deca-Durabolin comes in 1 mL pre-filled syringes containing 1 mL of light yellow oily liquid. Each pre-filled syringe contains 1 ml of 50 mg/mL nandrolone decanoate.

Composition Each ml of Deca-Durabolin contains 50 mg of the active ingredient nandrolone decanoate. The product also contains the inactive ingredients benzyl alcohol (0.1 mL) and arachis (peanut) oil making up the volume.

PHARMACOLOGY Pharmacodynamic properties Deca-Durabolin is an injectable anabolic preparation. The pharmacologically active substance is nandrolone. The decanoate ester gives the preparation a duration of action of about three weeks after injection. Nandrolone is chemically related to the male hormone. Compared to testosterone, it has an enhanced anabolic and a reduced androgenic activity. This has been demonstrated in animal bioassays and explained by receptor binding studies. The low androgenicity of nandrolone is confirmed in clinical use. In the human, Deca-Durabolin has been shown to positively influence calcium metabolism and to increase bone mass in osteoporosis. In women with disseminated mammary carcinoma, Deca-Durabolin has been reported to produce objective regressions for many months. Furthermore, Deca-Durabolin has a nitrogen-saving action. This effect on protein metabolism has been established by

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metabolic studies and is utilised therapeutically in conditions where a protein deficiency exists such as during chronic debilitating diseases and after major surgery and severe trauma. In these conditions, Deca-Durabolin serves as a supportive adjunct to specific therapies and dietary measures as well as parenteral nutrition. Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis. Pharmacokinetic properties Absorption Nandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days. Distribution In the blood, the ester is rapidly hydrolysed to nandrolone with a half-life of one hour or less. The combined process of hydrolysis, and distribution and elimination of nandrolone has a mean half-life of approximately 4 hours. Metabolism and excretion Nandrolone is metabolised by the liver. 19-Norandrosterone, 19-noretiocholanolone and 19-norepiandrosterone have been identified as metabolites in the urine. It is not known whether these metabolites display a pharmacological action.

INDICATIONS

Acute renal failure, chronic renal insufficiency and anaemia of chronic renal failure.

For the palliative treatment of inoperable mammary carcinoma.

Osteoporosis (where oestrogen therapy is contraindicated).

Aplastic anaemia.

Patients on long-term treatment with corticosteroids.

CONTRAINDICATIONS

Pregnancy.

Lactation.

Known or suspected prostatic carcinoma or mammary carcinoma in the male.

Hypersensitivity to the active substance, nandrolone decanoate, or any of the excipients, including arachis oil. Deca-Durabolin is therefore contraindicated in patients allergic to peanuts and soya (see PRECAUTIONS).

Nephrosis or the nephrotic phase of nephritis.

Liver disease with impaired bilirubin excretion.

Cardiac failure.

PRECAUTIONS

The recommended dosages should not be exceeded.

If signs of virilisation develop, discontinuation of the treatment should be considered.

The Deca-Durabolin injection should not be given if the patient is under the influence of heparin.

Anabolic steroids should be used with caution in patients with benign prostatic hypertrophy.

There have been rare reports of hepatocellular neoplasms and peliosis hepatic in association with long-term androgenic-anabolic steroid therapy.

Deca-Durabolin contains 100 mg benzyl alcohol per mL solution and must not be given to children younger than 3 years, including premature babies or neonates. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.

Deca-Durabolin contains arachis (peanut) oil and should not be taken/ applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut

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and allergy to soya, patients with soya allergy should also avoid Deca-Durabolin (see CONTRAINDICATIONS).

The packaging of this medicinal product contains natural rubber latex which may cause allergic reactions.

(Mis)use in sports: Patients who participate in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA-code before using this product as Deca-Durabolin can interfere with anti-doping testing.

Prescribers should be careful that Deca-Durabolin will not be misused and should be aware that some individuals may exhibit drug seeking behaviour. The misuse of anabolic substances to enhance ability in sports carries the following serious health risks and is to be discouraged: water retention; testicular atrophy and inhibition of spermatogenesis in males; oligomenorrhoea and virilisation, seen as hoarseness, acne and hirsutism in females; peliosis hepatis or other hepatoxicity (see ADVERSE EFFECTS).

Medical examination:

Physicians should consider monitoring patients receiving Deca-Durabolin before the start of

treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following

parameters:

- Digital rectal examination (DRE) of the prostate and PSA to exclude benign prostate

hyperplasia or a sub-clinical prostate cancer

- Hematocrit and hemoglobin to exclude polycythemia.

Conditions that need supervision:

Patients, especially the elderly, with the following conditions should be monitored for:

- Tumours Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal

metastases. In these patients hypercalcemia may develop spontaneously, also during

anabolic steroid therapy. The latter can be indicative of a positive tumour response to

the hormonal treatment.

- Pre-existing conditions In patients with pre-existing cardiac, renal or hepatic

insufficiency/disease anabolic steroid treatment may cause complications

characterized by edema with or without congestive heart failure. In such cases

treatment must be stopped immediately.

Patients who experienced myocardial infarction, cardiac-, hepatic- or renal

insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk

of deterioration on or reoccurrence of disease. In such cases treatment must be

stopped immediately.

- Diabetes mellitus Deca-Durabolin can improve the glucose tolerance in diabetic

patients.

- Anti-coagulant therapy Deca-Durabolin can enhance the anti-coagulant action of

coumarin-type agents.

Adverse events:

If anabolic steroid-associated adverse reactions occur, treatment with Deca-Durabolin should

be discontinued and, upon resolution of complaints, resumed with a lower dose.

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Virilization:

Patients should be informed about the potential occurrence of signs of virilization. In particular singers and women with speech professions should be informed about the risk of deepening of the voice. If signs of virilization develop, the risk/benefit ratio has to be newly assessed with the individual patient.

Paediatric Population:

In pre-pubertal children statural growth and sexual development should be monitored since

anabolic steroids in general and Deca-Durabolin in high dosages may accelerate epiphyseal

closure and sexual maturation.

Effects on Fertility In men, treatment with Deca-Durabolin can lead to fertility disorders by repressing sperm-formation. In women treatment with Deca-Durabolin can lead to an infrequent or repressed menstrual cycle. Use in Pregnancy (Category D) Deca-Durabolin is contra-indicated in women who are pregnant. There are no adequate data from the use of Deca-Durabolin in pregnant women. In view of the risk of virilization of the fetus, Deca-Durabolin should not be used during pregnancy. Treatment with Deca-Durabolin should be discontinued when pregnancy occurs Use in Lactation Contraindicated. Anabolic steroids may have a virilising effect on the neonate and the amount of nandrolone esters excreted in breast milk is unknown. Carcinogenicity Studies on the carcinogenic effects of nandrolone decanoate in animals have not been conducted. Genotoxicity Studies on the genotoxic effects of nandrolone decanoate have not been conducted. Effects on laboratory tests

Anabolics may decrease levels of radioactive iodine uptake.

Anabolic steroids may decrease levels of thyroxine-binding globulin resulting in decreased

total T4 serum levels and increase resin uptake of T3 and T4. Free thyroid hormone levels

remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Anabolics may cause alterations in the glucose tolerance test and metyrapone test (pituitary functioning).

INTERACTIONS WITH OTHER MEDICINES

Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase nandrolone

levels. Therefore, adjustment of the dose of Deca-Durabolin may be required.

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Anticoagulant therapy: Anabolic steroids may increase sensitivity to oral anticoagulants.

Dosage of the anticoagulants may have to be decreased in order to maintain the prothrombin

time at the desired therapeutic level. Patients receiving oral anticoagulant therapy require

close monitoring, especially when anabolics are started or stopped. High doses of Deca-

Durabolin may enhance the anti-coagulant action of coumarin-type agents. Therefore close

monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is

required during therapy.

Insulin and other hypoglycaemic agents: in diabetic patients the metabolic effects of anabolics

may decrease blood glucose and thereby decrease requirements for insulin and other

hypoglycaemic agents. Patients with diabetes mellitus should therefore be monitored

especially at the beginning or end of treatment and at periodic intervals during Deca-Durabolin

treatment.

ACTH or corticosteroids: The concurrent administration of anabolic steroids with ACTH or

corticosteroids may enhance oedema formations; thus these active substances should be

administered cautiously, particularly in patients with cardiac or hepatic disease or in patients

predisposed to oedema

Recombinant Human Erythropoietin: Combination of Deca-Durabolin (50-100 mg/week) with

rhEPO (recombinant human erythropoietin), especially in females, may enable a reduction of

the erythropoietin dose to reduce anaemia.

ADVERSE EFFECTS Adverse effects are dependant on dosage, dose interval and individual sensitivity. The adverse effects are due to the androgenic activity of the preparation.

Due to the nature of Deca-Durabolin, side effects cannot be quickly reversed by discontinuing

medication. Injectables in general, may cause a local reaction at the injection site.

System Organ Class

Common Uncommon Rare

General Water retention, Oedema

Endocrine

Virilisation (in females*) shown as: hoarseness acne hirsutism increased/decreased libido.

Inhibition of spermatogenesis Sperm count decreased Oligospermia Testicular atrophy Impotence Gynaecomastia Increased frequency of erections Increased penile size (pre-pubescent boys) Hypertrophy of the clitoris Increased growth of pubic hair Oligomenorrhoea Amenorrhoea

Metabolic Hyperlipidaemia Decreased serum HDL cholesterol

Haematological

Increased haemoglobin to abnormal high levels

Cardiovascular Hypertension

Gastrointestinal Nausea

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Hepatobiliary Abnormal liver function Jaundice Peliosis hepatitis

Genitourinary

Epididymitis Bladder irritability Reduced urine flow Benign prostate hyperplasia Priapism

Musculoskeletal Premature epiphyseal closure (in children)

Skin & Appendages

Acne

Oily skin Greasy hair Rash Pruritus Exanthema Urticaria at injection site Furunculosis

(* At high dosage, long term treatment and frequent administration, signs of virilisation may occur in women

who are sensitive to hormonal treatment. If signs of virilisation occur, interruption of treatment should be

considered. Hoarseness can be the first sign of voice changes that can be long-lasting and sometimes

irreversible.)

Others frequency unknown:

Respiratory, thoracic and mediastinal disorders Dysphonia

Injury, poisoning and procedural complications Intentional misuse

The terms used to describe the undesirable effects above are also meant to include synonyms and

related terms.

Paediatric population:

The following undesirable effects have been reported in pre-pubertal children using androgens:

precocious sexual development, an increased frequency of erections, phallic enlargement and

premature epiphyseal closure.

DOSAGE AND ADMINISTRATION Deca-Durabolin should only be administered by deep intramuscular injection. Vials and ampoules are intended for single use only.

Adults (including elderly): Renal conditions such as acute renal failure and chronic renal insufficiency: 25-50 mg every 2-

3 weeks. Initially, higher dosages (50 mg every week) may be required.

For the palliative treatment of inoperable mammary carcinoma: 50 mg every 2-3 weeks.

Osteoporosis (where oestrogen therapy is contraindicated): 50 mg every 2-3 weeks.

For patients on long-term treatment with corticosteroids: 50 mg every 2-3 weeks.

N.B. For an optimal anabolic effect it is necessary to administer adequate amounts of vitamins, minerals and protein in a calorie-rich diet.

For the treatment of anaemia: o Aplastic anaemia: 50-150 mg every week. o Anaemia of chronic renal failure: 100mg for females, 200mg for males once a week.

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After a satisfactory improvement or a normalization of the red blood cell picture has been obtained, treatment should be withdrawn gradually on the basis of regular monitoring of the haematological parameters. Should a relapse occur at any time whilst the dose is being reduced or after stopping the treatment, reinstitution of therapy should be considered. The onset of a therapeutic effect may vary widely among patients. If no satisfactory response occurs after 3-6 months of treatment, administration should be discontinued. Paediatric population: Deca-Durabolin is not recommended in paediatric patients (see PRECAUTIONS). Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Deca-Durabolin should be treated with caution. Method of administration: Deca-Durabolin should be administered by deep intramuscular injection.

OVERDOSAGE There are no specific recommendations for the management of overdosage with Deca-Durabolin. The acute intramuscular toxicity of nandrolone esters is very low.

PRESENTATION AND STORAGE CONDITIONS Deca-Durabolin Orgaject 50mg/ml solution for injection (AUST R 10655): 1 ml in a disposable glass syringe. Each pre-filled syringe is affixed with a needle closed by a needle shield of natural rubber latex (see PRECAUTIONS). Store below 25

0C and protect from light. Keep container in the original carton.

NAME AND ADDRESS OF THE SPONSOR Merck Sharp & Dohme (Australia) Pty Limited 54-68 Ferndell Street South Granville NSW 2142 Australia Merck Sharp & Dohme (New Zealand) Ltd PO Box 99 851 New Market Auckland 1149 New Zealand

POISON SCHEDULE OF THE MEDICINE Schedule 4 Prescription Only Medicine

DATE OF APPROVAL Date of TGA approval: 22 February 2007 Date of most recent amendment: 9 July 2013

The information supplied relates only to Deca-Durabolin 50mg and should not be used in relation to any other product which may also contain the same active ingredient.